T/CACM 1333.4-2019 Guidelines for Clinical Trial Design and Evaluation of Traditional Chinese Medicines for Common Diseases in Pediatrics Part 4: Diarrhea in Children
T/CACM 1333.4-2019 Guidelines for Clinical Trial Design and Evaluation of Traditional Chinese Medicines for Common Diseases in Pediatrics Part 4: Diarrhea in Children
Basic Information
Scope
Main technical content: This part is one of the standardization projects of the Chinese Society of Traditional Chinese Medicine - "Clinical Trial Design and Evaluation Technical Guidelines for Common Pediatric Diseases with Traditional Chinese Medicine". It was officially initiated in June 2017. Commissioned by the Pediatric Branch of the Chinese Society of Traditional Chinese Medicine and the Clinical Pharmacology Branch of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine First Affiliated Hospital took the lead in organizing domestic peer experts to establish the project group of this part. On the basis of the "Clinical Trial Design and Evaluation Technical Guidelines for New Drugs with Traditional Chinese Medicine for Common Pediatric Diseases - Rotavirus Enteritis in Children" (2013) of the Pediatric Branch of the Chinese Society of Traditional Chinese Medicine, this part expands the range of diseases, updates the technical content, and is revised. This part is guided by clinical value. Under the mode of disease-condition combination, it focuses on discussing the clinical positioning, trial design and implementation, and other related issues with the characteristics of diseases, children, and traditional Chinese medicine.